JABIL HEALTHCARE DR
⚠️ Moderate Risk
FEI: 3017913313 • San Cristobal, San Cristobal • DOMINICAN REPUBLIC
FEI Number
3017913313
Location
San Cristobal, San Cristobal
Country
DOMINICAN REPUBLICAddress
Itabo Industrial Park B, , San Cristobal, San Cristobal, Dominican Republic
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is JABIL HEALTHCARE DR's FDA import refusal history?
JABIL HEALTHCARE DR (FEI: 3017913313) has 2 FDA import refusal record(s) in our database, spanning from 7/7/2021 to 7/7/2021.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. JABIL HEALTHCARE DR's FEI number is 3017913313.
What types of violations has JABIL HEALTHCARE DR received?
JABIL HEALTHCARE DR has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about JABIL HEALTHCARE DR come from?
All FDA import refusal data for JABIL HEALTHCARE DR is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.